The European Commission has taken a significant step toward bolstering food safety by introducing the 16th Amendment to the Food Contact Plastic Regulation (EU 2023/1442). This regulatory update, recently published by the European Commission, brings about vital changes to substance authorizations and introduces new substances within the framework of Commission Regulation (EU) No 10/2011. The aim is to address scientific and technical advancements in the food contact materials (FCM) industry and resolve ambiguities in the application of the Regulation.
The changes, set to take effect on August 1, 2023, merely 20 days after publication, mark a substantial shift in the landscape of food contact plastic materials. Noteworthy modifications within the regulation encompass the elimination of entries, revised phthalate limits, alterations to existing entries, and the addition of new substances.
Eliminated Entries and Revised Phthalate Limits
Among the key amendments, Annex I of the regulation sees the removal of FCM No 96 – “Untreated wood flour and fibers” and FCM No 121 – “Salicylic acid,” thereby prohibiting their use in plastic food contact materials. This prohibition, however, won’t be immediate. Until February 1, 2025, manufacturers can still utilize these items in their products. Nevertheless, their availability is contingent upon submitting a specific-use authorization application within a 12-month period after the amendment’s enactment, specifically before August 1, 2024.
Moreover, five phthalate entries in Annex I have undergone revision to incorporate lower migration limits and a new group restriction number (Group 36). For instance, phthalates like DBP, BBP, DEHP, DINP, and DIDP have seen revisions in their specific migration limits, as detailed in Table 1.
Revised Additional Entries and Addition of New Substances
In addition to phthalates, revisions extend to various other substances listed in Annex I. Notably, FCM No 793 – “Triethanolamine” and FCM No 822 – “Perchloric acid, salts(perchlorate)” have had their individual specific migration limits (SMLs) removed. These entries are now referred to as new total specific migration limit—SML(T)—Group 37 and Group 38, respectively.
Additionally, the scope of the existing authorization for the use of diethyl[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl] methyl] phosphonate (FCM No 1007) has been extended for up to 0.2% in poly(ethylene 2,5-furandicarboxylate) (PEF). Similar extensions apply to the use of FCM 1076-phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypropyl [oxy (methyl-1,2-ethanediyl)], C10-16 alkyl esters and FCM 1059-Poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) (PHBH).
Introduction of New Food Contact Materials
The recent amendment also introduces five new substances authorized for use in manufacturing plastic FCMs. These include FCM No 1078, FCM No 1080, FCM No 1081, FCM No 1082, and FCM No 1083. Each substance has specific limitations and intended use cases, aimed at enhancing food safety across various applications.
Transition Period
To accommodate the industry’s adjustment to these regulatory changes, the transition period is in effect until February 1, 2025. During this time, plastic food contact materials complying with Regulation (EU) No 10/2011 can continue to be placed on the market. However, materials placed on the market prior to this date may remain available until stocks are depleted.
Within nine months of the amendment’s implementation, manufacturers of non-compliant intermediate products must inform users that these products cannot be used to manufacture plastic materials and articles for market placement once the transition period ends.